BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 3113832 · Received May 15, 2013

    Report

    Report Number
    2210968-2013-05476
    Event Type
    Injury
    Date Received
    May 15, 2013
    Report Date
    April 22, 2013
    Manufacturer
    ETHICON, INC
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY PROBLEMS, BOWEL PROBLEMS, ORGAN PERFORATION, RECURRENCE, DYSPAREUNIA AND VAGINAL SCARRING. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2005 AND ON (B)(6) 2010 FOR MEDICAL NECESSITY. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4). THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-05482. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-05482. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED FREQUENCY, URGENCY, INCONTINENCE, DYSURIA AND URINARY TRACT INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO TREAT STRESS URINARY INCONTINENCE ON (B)(6) 2004 AND (B)(6) 2010 MESH WAS PLACED INTO THE PATIENT'S BODY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING EROSION, FORMATION OF SCAR TISSUE, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215476 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON, INC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention